Senior Regulatory Affairs Manager – Medical Devices & Biologics

Organogenesis Inc.; Canton (MA); On-site; USD 119,000 - 140,000; Full time

Benefits offered by this job

401k plan

Medical, dental, vision

Health savings / flexible spending

Paid leave

Education assistance

Job summary

Organogenesis seeks an experienced regulatory affairs professional to manage regulatory requirements for medical devices and biologics, including HCT/Ps. You will develop regulatory strategies and submissions for FDA and international bodies, and guide product changes for US marketed products.

Role requires collaboration with development, manufacturing and quality teams, evaluation of changes for filing requirements, and strong knowledge of FDA, EU, and ICH regulations.

Qualifications

• BS degree in science, technology, engineering, or mathematics.
• Advanced degree and/or regulatory credentials (MS, RAC) preferred.
• 5+ years regulatory affairs experience in biotech.
• 3+ years developing regulatory strategies and preparing submissions.
• Experience with regulatory product lifecycle management.

Responsibilities

• Develop regulatory strategies and submissions for FDA and international regulators.
• Collaborate with process development, manufacturing and quality teams for submissions.
• Review protocols, reports, and labeling changes for regulatory impact.
• Ensure compliance with QSR, cGMP, and ICH/EU requirements.
• Lead regulatory strategy meetings and present requirements.

Skills

Regulatory strategy

Regulatory submissions

Regulatory standards

Documentation

Communication

Education

BS in science/engineering/math

MS or RAC preferred

Tools

Regulatory lifecycle management

PMA/IND/BLA/510(k) filings

Job description

Organogenesis seeks an experienced regulatory affairs professional to manage regulatory requirements for medical devices and biologics, including HCT/Ps. You will develop regulatory strategies and submissions for FDA and international bodies, and guide product changes for US marketed products.

Role requires collaboration with development, manufacturing and quality teams, evaluation of changes for filing requirements, and strong knowledge of FDA, EU, and ICH regulations.